MEM (ASX) MEM Discussion

Originally posted by Quest09: ↑

An IVF company in Brazil called Overture Life has just had an automated cryogenic freezing device for IVF cleared for use in Brazil by the Brazilian National Health Surveillance Agency (ANVISA). The device has been cleared for commercial sale and use (as per below screenshot).

As we know MEM has just started commercial discussions with a company called Androscience in brazil to introduce the Felix System into the Brazilian market, as per following link (Link to post about Brazil Androscience deal: https://hotcopper.com.au/posts/78693773/single ).

The interesting thing about this is that apparently, the Overture Life device was classified as a Class 1 medical device for the regulatory clearance process.....and here is the really interesting part...............registration for commercial sales of class 1 and class 2 devices in Brazil are described below, alongside the average timeframe to achieve registration (apparently it only takes 1 to 3 months for the process):

Key Differences and Timeframe for Registration :
Class I devices are non-invasive and pose minimal risk, requiring a simpler and faster approval process.

Class II devices may have some level of invasiveness or require additional documentation for safety compliance, making the approval process slightly longer than Class I devices.
Both classifications allow for a notification-based registration, avoiding the lengthy full registration process required for higher-risk devices like Class III and IV.

If my research is accurate, then MEM device could potentially be classified as a Class 1 or Class 2 device and therefore could potentially receive clearance for sale in as little as 3 months through a notification process provided by the Brazilian regulator.

Felix sales and a commercial deal for Felix sales in Brazil could be much closer than we think.

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Originally posted by kenjikool: ↑

It would be classified as class to and unfortunately due to the electrical process this will add to the time frame. But 3 months is not long and if they get the right investors that have the right channels it could be a fast process, thanks for posting something uselul.

Class II devices require notification rather than full registration, meaning ANVISA does not conduct an extensive technical review. The manufacturer or their Brazilian Registration Holder (BRH) submits an application with necessary documents, including a technical dossier, labeling, and instructions for use (IFU), which must be kept on file for potential audits. While the dossier is not submitted for review, it must be prepared in accordance with ANVISA’s requirements and available for inspection. All submissions must be in Portuguese, and compliance with Brazilian Good Manufacturing Practices is required, If the device is electromedical (like the Memphasys Felix device, which uses electrophoresis), an INMETRO certificatemay be required, which can take 3 to 12 months to obtain, depending on the complexity and testing requirements. This step, if applicable, must be completed before notification and could extend the overall timeline. Once the notification is approved, ANVISA issues a notification number, and the device can be marketed immediately. Class II notifications do not expire, unlike registrations for Class III and IV devices.

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It could potentially be a class 1 or a class 2 device.

You need to provide clear evidence for your statement regarding electricity, otherwise it can be considered nonsense.

Either way, the timeframe for both those processes (class 1 and class 2) is only 1 to 3 months.

By the way, a "thank you" is a step in the right direction, but the outstanding apology is still required.

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